Zimmer J, Bonertz A, Vieths S
Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, Langen, Germany.
Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, Langen, Germany.
Allergol Immunopathol (Madr). 2017 Dec;45 Suppl 1:4-11. doi: 10.1016/j.aller.2017.09.002. Epub 2017 Nov 9.
All allergen products for allergen immunotherapy currently marketed in the European Union are pharmaceutical preparations derived from allergen-containing source materials like pollens, mites and moulds. Especially this natural origin results in particular demands for the regulatory requirements governing allergen products. Furthermore, the development of regulatory requirements is complicated by the so far missing universal link between certain quality parameters, in particular biological potency, on the one hand and clinical efficacy on the other hand. As a consequence, each allergen product for specific immunotherapy has to be assessed individually for its quality, safety and efficacy. At the same time, biological potency of allergen products is most commonly determined using IgE inhibition assays based on human sera relative to product-specific in house references, ruling out full comparability of products from different manufacturers. This review article aims to summarize the current quality requirements for allergen products including the special requirements implemented for control of chemically modified allergen extracts (allergoids).
目前在欧盟市场上销售的所有用于变应原免疫疗法的变应原产品均为药物制剂，其来源于含变应原的原材料，如花粉、螨虫和霉菌。特别是这种天然来源对变应原产品的监管要求提出了特殊要求。此外，由于目前在某些质量参数（特别是生物效价）与临床疗效之间缺乏普遍联系，监管要求的制定变得复杂。因此，每种用于特异性免疫疗法的变应原产品都必须针对其质量、安全性和有效性进行单独评估。同时，变应原产品的生物效价最常用基于人血清的IgE抑制试验相对于特定产品的内部参考标准来确定，这排除了不同制造商产品的完全可比性。这篇综述文章旨在总结变应原产品当前的质量要求，包括对化学修饰变应原提取物（变应原类制剂）控制所实施的特殊要求。
